Description : Reverse payment settlements or “pay-for-delay agreements” between originators and generic drug manufacturers create heated debates regarding the balance between competition and intellectual property law. These settlements touch upon sensitive issues such as timely generic entry and access to affordable pharmaceuticals and also the need to preserve innovation incentives for originators and to strengthen the pipeline of life-saving pharmaceuticals. This book is one of the first to critically and comparatively analyse how such patent settlements and various other strategies employed by the pharmaceutical industry are scrutinised by both United States (US) and European courts and enforcement authorities, and to discuss the applicable legal tests and the main criteria used for their assessment. The book’s ultimate objective is to provide guidance to the pharmaceutical industry regarding the types of patent settlements, strategies and conduct which may be problematic from US antitrust and European Union (EU) competition law perspectives and to assist practitioners in structuring settlements which are both efficient and compliant. To this end, an exhaustive legal analysis of some of the most controversial issues regarding pharmaceutical patent settlements is provided, including: – the lengthy split among US Circuit Courts on the issue of pay-for-delay settlements, its resolution by the US Supreme Court in FTC v. Actavisand subsequent jurisprudence; – the decision of Lundbeck v. Commissionby the European General Court and the Servier decision of the European Commission; – the Roche/Novartisdecision of the European Court of Justice and the most important decisions by National Competition Authorities on pharma patent settlements in the EU; – an overview of other types of strategies such as product-hopping and product reformulations, no-authorised generic commitments, problematic side-deals, mechanisms affecting generic substitution; – the rejection of the “scope of the patent” test in both the US and the EU and the balancing of patent law and antitrust law considerations in the prevailing applicable tests; – the benefits of settlements and the main criteria for assessing their legitimacy under US antitrust and EU competition law. The analysis provides concrete examples of both illegitimate and legitimate settlements and strategies, emphasising on conduct that falls within a grey zone and on the circumstances and criteria under which such conduct could be deemed problematic from an antitrust perspective. This book will serve as a valuable guide for pharmaceutical companies wishing to minimise the risk of engaging in conduct that could potentially infringe US antitrust and EU competition law. It further aims to save courts and enforcement agencies and also practitioners and academics considerable time and resources by providing an exhaustive analysis of the relevant caselaw, with the ultimate goal to increase legal certainty on the most controversial aspects of patent settlements in the pharmaceutical industry.
Description : Although competition law and intellectual property are often interwoven, until this book there has been little guidance on how they work together in practice. As the intersection between the two fields continues to grow worldwide, both in case law and in regulation, the book's markets-based approach, focusing on sectors such as pharmaceuticals, IT, telecoms, energy and agriculture in eleven of the world's most active jurisdictions, provides a much-needed in-depth understanding of how this interplay reveals itself among the different legal systems. Written by a range of authors including judges, regulators, academics, economists and practitioners in both fields, the book provides an international comparative perspective as well as detailed analysis of specific cases, policies and proposals for change. Among the issues and topics covered are the following: – free movement of goods and the protection of intellectual property rights; – standard essential patents & injunction in patent cases; – intellectual property rights between technological development and consumer protection; – geo-blocking; – online platforms and antitrust; – excessive prices. In this context, special attention is paid throughout to the increasing dialogue among Competition Authorities and between Judges and Competition Authorities around the world. As matchless remedy for the lack of uniformity heretofore, the book's investigation of the nexus between competition law and intellectual property in different sectors and in various countries takes a giant step towards a more-balanced approach and more-levelled regulation and practices. It will be warmly appreciated by policy makers, decision makers, regulators, practitioners and academics in both competition law and intellectual property fields
Description : Every October the Fordham Competition Law Institute brings together leading figures from governmental organizations, leading international law firms and corporations and academia to examine and analyze the most important issues in international antitrust and trade policy of the United States, the EU and the world. This work is the most definitive and comprehensive annual analysis of international antitrust law and policy available anywhere. Each annual edition sets out to explore and analyze the areas of antitrust/competition law that have had the most impact in that year. Recent "hot topics" include antitrust enforcement in Asia, Latin America: competition enforcement in the areas of telecommunications, media and information technology. All of the chapters raise questions of policy or discuss new developments and assess their significance and impact on antitrust and trade policy. The chapters are revised and updated before publication when necessary. As a result, the reader receives up-to-date practical tips and important analyses of difficult policy issues. The annual volumes are an indispensable guide through the sea of international antitrust law. The Fordham Competition Law Proceedings are acknowledged as simply the most definitive US/EC annual analyses of antitrust/competition law published. Value Package + Buy International Antitrust Law and Policy: Fordham Competition Law 2009 - Downloadable Electronic Product and get International Antitrust Law & Policy: Fordham Competition Law 2009 at an additional 50% off our everyday low price. Total Price: $250.00 Price for the Bundle: $187.50 This Item: International Antitrust Law & Policy: Fordham Competition Law 2009 International Antitrust Law and Policy: Fordham Competition Law 2009 - Downloadable Electronic Product
Description : Intellectual property law is built on constitutional foundations and is underpinned by the twin freedoms of freedom of expression and freedom of economic enterprise. In this thoughtful evaluation, Gustavo Ghidini offers up a reconstruction of the core features of each intellectual property paradigm, including patents, copyright, and trademarks, suggesting measures for reform to allow intellectual property to become socially beneficial for all.
Description : This book provides a systematic analysis of the law and practice of EU competition and trade in the pharmaceutical sector. Authored by leading private practitioners, economists, scholars and high-level officials at competition regulators, this work provides valuable insider knowledge on the application of law and policies to the pharmaceutical industry. The work contains extensive commentary on the legislation and the latest case law and administrative precedents in this sector, at both EU and national level, including certain significant jurisdictions (e.g., the US, China). Coverage of various key developments includes the recent pay-for-delay antitrust investigations, the perennial issues around parallel trade, and an examination of mergers among pharmaceutical companies and medical devices manufacturers. In addition to the legal analysis, it offers vital economic and business perspectives to ensure that the reader has the full range of tools with which to prepare for cases and conduct transactions within the pharmaceutical industry.
Description : This publication examines how drug originator manufacturers manage to shield their products from competition. It characterizes the pharmaceutical industry in detail and analyzes actions that violate antitrust laws in the USA and/or the European Union. The publication examines, for example, pay-for-delay strategies, market foreclosure, resale price maintenance, but also mergers and acquisitions, while taking into account market specificities such as the unique research and development process. The study explains why drug prices sometimes remain at elevated levels even after the drug’s patent protection has expired. Knowing the characteristics of such anticompetitive strategies helps customers such as health insurance companies to develop effective counter-strategies.
Description : 'This volume contains many excellent chapters on some of the most cutting edge topics in competition law today. Among the contributions are assessments of new approaches to competition law analysis, analyses of central and controversial topics in the relationship between competition law and intellectual property, and explorations of new transnational developments in China and elsewhere. The chapters range from studies of specific cases to broad interpretations of major trends. I found many of them to be highly insightful and very useful.' – David J. Gerber, Chicago-Kent College of Law, US 'This fresh collection of essays by scholars from around the world lives up to its title: it stakes out more common ground for the competition law systems of nations. The chapters result from the fourth annual conference of the Academic Society for Competition Law (ASCOLA). The essays cover major issues that reverberate around the world today, including: How should we think about the economic foundations of competition law in view of new research on behavioral economics and consumer choice? What is the future of the treatment of resale price maintenance? What is the proper fit of intellectual property with competition law? And how do we promote competition law and policy across borders? The collection offers insight from law, economics, political science, business strategy, and history.' – Eleanor Fox, New York University, US In recent years, an impressive proliferation of competition laws has been seen around the world. Whilst this development may lead to greater diversity of approaches, economic arguments may promote convergence. The contributions to this book look at a number of most topical issues by asking whether the competition world is turning more towards convergence or diversity. These issues include, among others, the changing role of economics in times of economic crises and political change, the introduction of criminal sanctions, resale-price maintenance, unilateral conduct and the application of competition law to intellectual property and state-owned enterprises. More Common Ground for International Competition Law will appeal to academics, PhD students, and postgraduate students law and economics, members of competition agencies, legal practice and international business.